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news.Endologix, a developer of minimally invasive treatments for vascular diseases, has announced the FDA approval of the pre-market approval supplement for its Powerlink XL sSystem, which includes new suprarenal stent grafts as well as the new Powerlink XL stent graft.
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This approval substantially broadens the company’s treatment indications for the Powerlink system, which is used in the minimally invasive treatment of abdominal aortic aneurysms (AAA).
The Powerlink XL System was evaluated in an investigational device exemption clinical study and approved for the treatment of AAA patients with proximal aortic necks between 23mm and 32mm.
John McDermott, president and CEO of Endologix, said: “This approval is important for patients with AAA, because the Powerlink XL sSystem offers the lowest profile catheter of all commercially available devices in the US indicated for aortic necks greater than 26mm.”